Bacterial vaginosis is associated with increased transmission of sexually transmitted infections, preterm labor, post-surgical infections, and endometritis.
Intravaginal boric acid has been used for over a hundred years to treat vaginal infections, such as bacterial vaginosis. Boric acid is inexpensive, accessible, and has shown to be an effective treatment for other infections, such as vaginal candidiasis. To date, there has been no clinical trial evaluation of boric acid effectiveness to treat bacterial Boric acid douche. The study will enroll a minimum of women of 16—50 years of age who are symptomatic with bacterial vaginosis.
Eligible participants will have Amsel and Nugent scores confirming bacterial vaginosis. Women who are pregnant or menopausal or have other active co-infections will be excluded. Consenting participants who meet exclusion and inclusion criteria will be randomly assigned to one of three treatment groups: Self-administration of treatment intravaginally for 10 days will be followed by clinical assessment at 7 and 30 days days 17 and 40, respectively after the end of the treatment phase.
Primary outcome is a non-inferiority, per-protocol comparison of the effectiveness of boric acid with that of metronidazole at day 17, as measured by the Nugent score in 16—50 year olds. This study will be the first to determine whether intravaginal boric acid is non-inferior to metronidazole in the treatment of bacterial vaginosis in symptomatic women.
Bacterial vaginosis is associated with postpartum endometritis, increased risk of post-surgical infections, pelvic inflammatory disease, increased risk of spontaneous abortions, preterm rupture of membranes and delivery, and increased risk of sexually transmitted infection acquisition, including: Bacterial vaginosis is caused by a shift from the normal peroxidase-producing lactobacillus-dominant vaginal flora to a several-log Boric acid douche in total Boric acid douche colony count, which may include a mix of anaerobes, genital mycoplasmas, and Gardnerella vaginalis [ 17 ].
It can also be painful, and is associated with dysuria Boric acid douche dyspareunia in symptomatic women [ 8 ]. Bacterial vaginosis is diagnosed in the presence of three of the four Amsel criteria: Current recommended antimicrobial treatments for BV in non-pregnant, symptomatic women include oral and intravaginal metronidazole or clindamycin [ 1813 ].
Oral and intravaginal metronidazole are considered equivalent and effective treatments for BV [ 91114 — 16 ]. At present, oral or vaginal metronidazole is the only recommended treatment option for recurrent BV, as is vaginal Boric acid douche for long-term suppression [ 921 ].
Boric acid H 3 BO 3 has been used for over a hundred years for the treatment of vaginal infections and is commonly used by physicians and patients as an inexpensive, easy to use, accessible treatment of candidiasis and BV [ 22 ].
In addition to its proven Boric acid douche in the treatment of candidal infections, [ 22 — 31 ] including those that did not resolve Boric acid douche usual antifungal treatment [ 24 — 28 ], H 3 BO 3 use seemed to be associated with a reduced number of co-infections with BV [ 25 ]. A retrospective study suggests clinical improvement in seven of nine patients following treatment with mg intravaginal H 3 BO 3 for 14 nights in Boric acid douche with a mixed infection of T.
No studies to date have determined H 3 BO 3 effectiveness in the treatment of acute, chronic, or recurrent BV. The objective of this study was to determine whether intravaginal H 3 BO 3 is comparable to standard treatment, metronidazole, for the cure of BV in symptomatic women.
This trial is registered with ClinicalTrials. We felt it important to include a placebo treatment arm in this study for different reasons: Recruitment began February for a minimum of volunteers through participating family practice clinics in British Columbia, Canada. Volunteer participating clinics represent a spectrum of different types of practice across British Columbia: Clinics were recruited to the study through province-wide medical journal advertisements, university family practice departmental email advertisements, personal emails, faxes, phone calls and in person.
Eligible clinics agreed to recruit five or more Boric acid douche meeting inclusion and exclusion criteria and to use the study treatments and prepared packages provided. Women who present to their clinician at participating family practice clinics with symptoms of BV are offered an opportunity to participate in the study.
Participants are given the informed consent form explaining the three possible treatment arms, and that participation will include three visits the initial visit, day 0; day 17—19 [7—9 days after the treatment end to measure the primary endpoint]; Boric acid douche day 40—42 [30—32 days after the treatment end as a secondary endpoint] involving three examinations, including a pregnancy test. There are no visits to the clinic while the participants are administering the day treatment unless there are any concerns.
In general, participants cannot be pregnant, menopausal, have another vaginal infection, or have an intrauterine device.
Written consent is obtained prior to treatment intervention. Women who choose to participate receive their medication for free. There is a draw for recruited women to win a small gift certificate.
These numbers then become the new identification numbers on the treatment packs. All treatment packs are then distributed to participating clinics by the study pharmacist who sends out five sequentially numbered treatment packs to each participating site as sites are recruited to the study.
The study pharmacist is the only person with access to the master code Boric acid douche the randomized treatments.
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The participants, recruiting clinicians and investigators will be blinded to the controlled and randomized day treatment pack that is given to the study participant. Blinded recruiting clinicians give out the physically indistinguishable treatment package in allocated randomization order to the sequential participants on enrollment day day 0.
On day 0, the enrolled participants will be blindly and randomly assigned to one of three day treatments minimum of 80 women per treatment arm: Product DIN packaged by the study pharmacist.
There is no detectable difference between the treatments in either appearance or scent. On day 0, a pregnancy Boric acid douche will be conducted and history will be collected by the clinician. Vaginal discharge will also be tested for pH one of the four Amsel criteria. Where facilities permit; clue cells will be examined, as the fourth Amsel criterion. On this day, the recruiting clinician Boric acid douche confirm participation, eligibility, and exclusion criteria using provided protocol forms and will collect the signed consent form and the demographic and medical history questionnaires provided.
The blinded treatment pack containing either H 3 BO 3 compounded in emollient cream, metronidazole cream, or emollient cream is allocated by the recruiting clinician in the randomization order to sequential participants on day 0.
The participant package also contains: Participants will self-administer the blinded treatment cream intravaginally each evening immediately prior to sleep for 10 days. The participants will be instructed to use a provided pad during day and night. Each participant will record daily compliance, side effects, and Boric acid douche in the journal provided.